Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b study

Abstract

Scalp psoriasis is common and difficult to treat. To evaluate efficacy and safety of tildrakizumab for the treatment of scalp psoriasis. In this Phase 3b, randomized, double-blind, placebo (PBO)-controlled study (NCT03897088), patients with moderate-to-severe plaque psoriasis affecting the scalp (Investigator Global Assessment modified [IGA mod] 2011 [scalp] ≥3, Psoriasis Scalp Severity Index [PSSI] ≥12, ≥30% scalp surface area affected) received tildrakizumab 100mg or PBO at W0 and W4. The primary endpoint was IGA mod 2011(scalp) score of "clear" or "almost clear" with ≥2-point reduction from baseline at W16 (IGA mod2011 [scalp] response). Key secondary endpoints were PSSI 90 response at W12 and W16 and IGA mod 2011 (scalp) response at W12. Safety was assessed from adverse events. Of patients treated with tildrakizumab (n=89) vs PBO (n=82), 49.4% vs 7.3% achieved IGA mod 2011 (scalp) response at W16 (primary endpoint) and 46.1% vs 4.9% at W12; 60.7% vs 4.9% achieved PSSI 90 response at W16 and 48.3% vs 2.4% at W12 (all P<.00001). No serious treatment-related adverse events occurred. Only short-term data are presented. Tildrakizumab was efficacious for the treatment of scalp psoriasis with no new safety signals.